Posted: 19 Jun 2019 10:30 PM PDT
The government lost a significant battle in its aggressive prosecutions of individuals involved in the New England Compounding Center (NECC) disaster, in which the vilified, and now-defunct, NECC “compounded” contaminated batches of drugs that led to a multitude of deaths and injuries. Gregory Conigliaro, a co-owner of NECC, and Sharon Carter, the Director of Operations, were convicted by unanimous jury verdict for conspiring to defraud the United States, also known as a Kleinconspiracy. The core allegation was that the defendants were engaged in a concerted effort to hold out NECC as a “more or less conventional pharmacy” when in actuality NECC was operating as a drug manufacturer. The distinction carried significant regulatory impact because, at that time, FDA only regulated drug manufacturers, while traditional pharmacy compounders were regulated by the state boards of pharmacy.
Both pre-, during, and post-trial, defendants argued that there was no discernible federal law defining any clear distinction between a compounding pharmacy and a drug manufacturer, and thus that it was a “legal impossibility” for defendants to have defrauded FDA. “Legal impossibility” applies when the actions of a defendant, even if carried out as desired, would not constitute a crime (e.g., smoking marijuana in Massachusetts in the mistaken belief that the recreational use of marijuana was illegal in the state). On June 7, 2019, in response to the defendants’ Rule 29 motions for acquittal, U.S. District Judge Richard G. Stearns agreed and acquitted these defendants. The court recognized that the “legal impossibility” defense had not proved effective in any precedential case, but reasoned that the facts, coupled with basic principles of lenity and due process, required its application in this case.
The court was convinced by arguments that the government failed to meet its burden of proof on a required element of the Klein conspiracy, namely that FDA was in fact exercising regulatory authority over compounders. The court recounted the history of FDA’s authority to regulate compounding activities, noting that Congress created a “regulatory lacuna” because it failed to provide clarity on the dividing line between drug compounding and manufacturing, causing confusion among state and federal regulators as to who was responsible. And the court relied heavily on FDA’s own statements to Congress and its recognition that compounding pharmacies fulfilled a public health need for supplying hospitals with drugs otherwise unavailable to them. Ultimately, the court was unwilling to impose criminal liability on such a “shaky foundation.”
To date, thirteen employees have pled guilty or been convicted of various charges, including mail fraud and RICO violations. We expect to see the other individuals previously convicted for participating in the Klein conspiracy to raise these same arguments in whatever legal mechanisms remain available to them. The U.S. Attorney in Massachusetts, Andrew Lelling, has stated that his office is considering whether to appeal Judge Stearns’ ruling.
Both pre-, during, and post-trial, defendants argued that there was no discernible federal law defining any clear distinction between a compounding pharmacy and a drug manufacturer, and thus that it was a “legal impossibility” for defendants to have defrauded FDA. “Legal impossibility” applies when the actions of a defendant, even if carried out as desired, would not constitute a crime (e.g., smoking marijuana in Massachusetts in the mistaken belief that the recreational use of marijuana was illegal in the state). On June 7, 2019, in response to the defendants’ Rule 29 motions for acquittal, U.S. District Judge Richard G. Stearns agreed and acquitted these defendants. The court recognized that the “legal impossibility” defense had not proved effective in any precedential case, but reasoned that the facts, coupled with basic principles of lenity and due process, required its application in this case.
The court was convinced by arguments that the government failed to meet its burden of proof on a required element of the Klein conspiracy, namely that FDA was in fact exercising regulatory authority over compounders. The court recounted the history of FDA’s authority to regulate compounding activities, noting that Congress created a “regulatory lacuna” because it failed to provide clarity on the dividing line between drug compounding and manufacturing, causing confusion among state and federal regulators as to who was responsible. And the court relied heavily on FDA’s own statements to Congress and its recognition that compounding pharmacies fulfilled a public health need for supplying hospitals with drugs otherwise unavailable to them. Ultimately, the court was unwilling to impose criminal liability on such a “shaky foundation.”
To date, thirteen employees have pled guilty or been convicted of various charges, including mail fraud and RICO violations. We expect to see the other individuals previously convicted for participating in the Klein conspiracy to raise these same arguments in whatever legal mechanisms remain available to them. The U.S. Attorney in Massachusetts, Andrew Lelling, has stated that his office is considering whether to appeal Judge Stearns’ ruling.
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